Baha
Baha BP110 Power tamper-proof battery doors Champagne blonde
4manufacturers in China registered for this device type
98catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Henan (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Zdeer Technology (Henan) Co., Ltd. | Xuchang | Henan | Remanufacturer | 9 |
| Shenzen Magnet Technology Co., Ltd. | Shenzen | Guangdong | Manufacturer | 2 |
| Sonitus Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Specification developer | 1 |
Record
| Listed by | Cochlear Bone Anchored Solutions AB, Sweden |
|---|---|
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K110996 |
| Record published | 2017-06-07 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature -20 to 50 °C |
| Sizes | Length 3 to 50 mm; length 75 to 150 cm; outer diameter 2 to 30 mm; weight 0.4 g |
| Distribution end date | 2025-05-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P806693 | In distribution | ||
| 93089 | 2 | In distribution | |
| 90410 | Length 8.5 mm | In distribution | |
| 92145 | In distribution | ||
| 90784 | In distribution | ||
| 93197 | In distribution | ||
| 90381 | Length 25 mm | In distribution | |
| 90480 | Length 3 mm | In distribution | |
| 91040 | In distribution | ||
| 92141 | Length 4 mm | In distribution | |
| 90417 | Drill 4 mm | In distribution | |
| 90146 | In distribution | ||
| 90620 | In distribution | ||
| 94223 | In distribution | ||
| 95460 | In distribution | ||
| 92131 | Length 9 mm | In distribution | |
| 92834 | 2 | In distribution | |
| 93090 | 2 | In distribution | |
| 92127 | Length 6 mm | In distribution | |
| 90776 | Abutment 5.5 mm | In distribution | |
| 92128 | Implant 4 mm | In distribution | |
| 93339 | In distribution | ||
| 94175 | 4 | In distribution | |
| 92133 | Abutment 8.5 mm | In distribution | |
| 92137 | Healing cap 20 mm | In distribution | |
| 95809 | 6 | In distribution | |
| 90801 | Outer Diameter 6.5 mm | In distribution | |
| 90415 | Drill 3+4 mm | In distribution | |
| 92138 | Outer Diameter 30 mm | In distribution | |
| 92140 | Length 3 mm | In distribution | |
| 92146 | In distribution | ||
| 90802 | Healing cap 14 mm | In distribution | |
| 90434 | Flange fixture 4 mm with abutment | In distribution | |
| P803254 | In distribution | ||
| 92126 | Implant 3 mm with 6mm abutment | In distribution | |
| 92832 | 2 | In distribution | |
| 90436 | Length 7 mm | In distribution | |
| 93091 | 2 | In distribution | |
| 90780 | Length 3 mm | In distribution | |
| 92130 | Abutment 6mm | In distribution | |
| 90474 | In distribution | ||
| 90360 | In distribution | ||
| 90362 | In distribution | ||
| 92836 | 2 | In distribution | |
| 91113 | In distribution | ||
| 95459 | In distribution | ||
| 90778 | Length 4 mm | In distribution | |
| 90774 | Length 7 mm | In distribution | |
| 90430 | Length 3 mm | In distribution | |
| 95478 | In distribution | ||
| 90842 | Outer Diameter 2 mm | In distribution | |
| 92136 | Weight 0.4 g | In distribution | |
| 92837 | 2 | In distribution | |
| 92132 | Abutment 5.5 mm | In distribution | |
| 90446 | Length 50 mm | In distribution | |
| 90909 | In distribution | ||
| 92833 | 2 | In distribution | |
| 92144 | In distribution | ||
| HIB 002-0 | In distribution | ||
| 94125 | In distribution | ||
| 90432 | Flange fixture 4 mm | In distribution | |
| 92129 | Implant 4 mm | In distribution | |
| P806653 | In distribution | ||
| 95948 | In distribution | ||
| 90416 | Drill 3 mm | In distribution | |
| 93363 | Drill 3+4 mm | In distribution | |
| 92835 | 2 | In distribution | |
| 90800 | In distribution | ||
| 93092 | 2 | In distribution | |
| 92346 | Implant 4 mm with 9mm abutment | In distribution | |
| HIB 003-0 | In distribution | ||
| 95430 | In distribution | ||
| 90305 | Length 5.5 mm | In distribution | |
| 90627 | Length 75 cm | Withdrawn | |
| 95448 | Withdrawn | ||
| 92843 | Withdrawn | ||
| 90171 | Withdrawn | ||
| 90185 | Withdrawn | ||
| 90068 | Withdrawn | ||
| 92844 | Withdrawn | ||
| 92830 | 2 | Withdrawn | |
| 90450 | Length 100 cm | Withdrawn | |
| 90629 | Length 150 cm | Withdrawn | |
| 90065 | Withdrawn | ||
| 91868 | Withdrawn | ||
| 92842 | Withdrawn | ||
| 92841 | Withdrawn | ||
| 90067 | Withdrawn | ||
| 93088 | 2 | Withdrawn | |
| P736025 | Withdrawn | ||
| 90625 | 100 cm long cable | Withdrawn | |
| 92845 | Withdrawn | ||
| 93087 | 2 | Withdrawn | |
| 92846 | Withdrawn | ||
| 92840 | Withdrawn | ||
| 90138 | Withdrawn | ||
| 92831 | 2 | Withdrawn | |
| 90623 | Length 75 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ponto | Oticon Medical AB | 172 |
| Hearing Aid, Bone Conduction | BHM-Tech Produktionsgesellschaft m.b.H. | 99 |
| Otomag™ Attract™ Magnetic Spacer | Medtronic Xomed, Inc. | 23 |
| Attract™ | Medtronic Xomed, Inc. | 22 |
| Otomag™ Alpha 2 Sound Processor | Medtronic Xomed, Inc. | 21 |
| Hearing Aid, Bone Conduction | Medtronic Xomed, Inc. | 21 |
| contact | BHM-Tech Produktionsgesellschaft m.b.H. | 21 |
| contact mini | BHM-Tech Produktionsgesellschaft m.b.H. | 12 |
| Otomag™ Alpha (M) Magnetic Implant | Medtronic Xomed, Inc. | 6 |
| contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
| contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
| Baha 5 SuperPower Actuator unit | Cochlear Bone Anchored Solutions AB | 4 |
Showing 12 of 230. All products under Hearing Aid, Bone Conduction
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cochlear Americas | 510(k) number | 2018-12-18 | Class II | Packaging process control | Product was packaged with the Incorrect tamper proof battery door. | 50 units | 2021-01-28 |
| Cochlear Americas | 510(k) number | 2014-04-09 | Class II | Process control | Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient’s skin. | 288 | 2014-10-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.